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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided for 1 out of 2 malfunctions, therefore, a lot history review was performed. The sample was not returned to the manufacturer for inspection/evaluation. For one of the two malfunctions, medical records were provided and reviewed, therefore the investigation is confirmed for filter tilt, perforation and filter limb detachment. Medical record was not provided for another malfunction; therefore, the investigation is inconclusive for the alleged filter limb detachment, perforation and filter tilt as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based on the available information, the definitive root cause is unknown. The devices are labeled for single use.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicates that model rf048f vena cava filter allegedly tilted, perforated and struts detached. These reports were received from various sources. Of the two malfunctions, both involved patients with no patient consequences. One patient was female with age (b)(6) years old and weight was not provided. Age, weight and gender for the remaining malfunction was not provided.

 
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Brand NameRECOVERY FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10305153
MDR Text Key199838680
Report Number2020394-2020-04776
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF048F
Device LOT NumberGFPE3160,UNKNOWN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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